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QL1706 in Combination With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma

NCT06852456 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-28

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled Phase II/III clinical trial to evaluate the perioperative treatment with QL1706 in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma. The primary objective of the Phase II is to evaluate the pathological complete response rate of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma; the primary objective of the Phase III is to compare event-free survival of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy versus placebo in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma.

Conditions

  • Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

DRUG

Iparomlimab and Tuvonralimab (QL1706)Injection

PD-1/CTLA-4

DRUG

Paclitaxel

Chemotherapy

DRUG

Cisplatin

Chemotherapy

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2030-12-31
Completion
2034-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06852456 on ClinicalTrials.gov